Preemption Archives - Faegre Drinker on Products

Subject: Preemption

Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects. Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so. Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).

Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies. Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation. The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.

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Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.

In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn. She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

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Ninth Circuit Affirms Exclusion of Expert and Resulting Summary Judgment in In re: Incretin-Based Therapies MDL

Early last year, the In re: Incretin-Based Therapies MDL court held that the plaintiffs’ warnings claims were preempted, excluded plaintiffs’ general causation experts, and granted summary judgment to all defendants on dual preemption and causation grounds. In re: Incretin-Based Therapies Prods. Liab. Litig., 524 F. Supp. 3d 1007 (S.D. Cal. 2021). For context, that was the second time the defendants won summary judgment; the Ninth Circuit had reversed an earlier preemption victory in an opinion that predated the Supreme Court’s decision in Albrecht. In re Incretin-Based Therapies Prods. Liab. Litig., 721 F. App’x. 580 (9th Cir. 2017). Now, however, the Ninth Circuit has affirmed summary judgment as to one defendant (Novo Nordisk A/S (“Novo”)). In re: Incretin-Based Therapies Prod. Liab. Litig., 2022 WL 898595 (9th Cir. Mar. 28, 2022).

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Another Brick in the Wall: The District Court Finds Preemption in Fosamax Case After Remand From the Supreme Court

We have written before about the Supreme Court’s impossibility preemption decision, Merck Sharpe & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019) (Albrecht) (here, here, here, and here), highlighting some open questions and uncertainties that might come into play on remand. Albrecht held that impossibility preemption is a question of law for the court, not for the jury, “elaborated” on the “clear evidence” standard arising from Wyeth v. Levine, 555 U.S. 555 (2009) (Wyeth), and remanded to the Third Circuit for determination of the preemption issue. That court in turn remanded to the District of New Jersey and further directed the district court “to determine the effect of the FDA’s Complete Response Letter and other communications with Merck on the issue of whether the agency actions are sufficient” to find preemption.

We predicted that the decision on remand would be “interesting” and opined that the case for preemption was “strong.” We now have that decision, In re Fosamax (Alendronate Sodium) Prod. Liab. Litig., 2022 WL 855853 (D. N.J. Mar. 23, 2022) (Fosamax), and we were right on both counts.

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How the Anti-Drunk Driving Technology Mandated by Recent Legislation May Impact the Liability of Automobile Manufacturers and the Future of Products Liability Law for Autonomous Vehicles

The Infrastructure Investment and Jobs Act (the “Act”), signed into law on November 15, 2021, has been followed closely by the transportation sector. One section of the Act has the potential to impact the landscape of automotive products liability litigation.

Section 24220 requires automobile manufacturers to equip new passenger vehicles with advanced drunk and impaired driving prevention technology. Infrastructure Investment and Jobs Act, Pub. L. No. 117-58, § 24220, 135 Stat. 429, 831-833 (2021).

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Ninth Circuit Affirms Dismissal of Breast Implant Cases on Preemption Grounds

The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA). Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.

In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines. The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.

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